OnCo
ideasIdea

A national non-profit contract research organisation for academic oncology trials

Running an early trial properly requires monitors, data managers, safety reporting and regulatory filings that universities cannot afford from commercial providers. A public not-for-profit would do this work at cost.

A publicly-owned or non-profit CRO providing sponsor-level services (protocol development, regulatory submissions, monitoring, pharmacovigilance, data management, statistics) to academic phase 1 and 2 oncology trials at cost, funded partly by a core grant and partly by fees charged to grants. Academic trials fail or stall for operational, not scientific, reasons; commercial CRO fees consume a large share of academic trial budgets. Precedents include the UK's NIHR clinical research network infrastructure, the EORTC headquarters model for European academic trials, and NCI's CTEP for investigational agents.

Hypothesis
Academic trials supported by a non-profit CRO complete recruitment and report results at least 30% faster than academic trials using commercial or in-house ad hoc support, at lower total cost per patient.
Rationale
EORTC and the German and UK cooperative trials units show that shared professional infrastructure lifts completion rates and quality; a non-profit CRO extends this from cooperative-group phase 3 to the early-phase academic trials where the valley of death is deepest.
What would test it
Fund a pilot CRO to sponsor twenty academic phase 1/2 oncology trials and compare start-up time, recruitment velocity, protocol deviations and reporting time against a matched set of contemporaneous academic trials.
Maturity
speculative
Who has to act
policy
Cost to try
Large (over $50M)
Years to first evidence
4
Bottlenecks it attacks

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